Trial Outcomes & Findings for A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (NCT NCT04505722)

NCT ID: NCT04505722

Last Updated: 2025-02-04

Results Overview

Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription/polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate \>= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate \>= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate \>=30 breaths/minute, heart rate \>=125 beats/minute, oxygen saturation (SpO2) \<= 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 44325 participants
• Primary outcome timeframe: From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6
• Results posted on: 2025-02-04

Participant Flow

A total of 44325 participants were randomized, of which 1 participant was randomized in error due to lack of a signed informed consent form. This participant has not been included in the analysis.

Due to change in the planned analysis, combined data of "double blind (DB)" and "open label (OL)" phase was collected and analyzed after completion of the double-blind phase. Results of safety outcome measures (OMs) were also collected and analyzed for combined DB and OL phase. Hence, safety data is reported only in adverse event section and not repeated in the OMs section. In all-cause mortality section out of 324 deaths, 1 death was not related to Adverse event.

Participant milestones

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	Combined Double-blind and Open-label Phase: All Participants Participants received a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine or placebo as IM injection on Day 1. At Month 6/unblinding visit, post emergency use authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5\*10\^10 vp. As of implementation of protocol amendment 3, participants were allowed to have an outside COVID-19 vaccine. As of implementation of protocol amendment 6, at Year 1 (open label booster vaccination phase), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) with the Ad26.COV2.S vaccine, and/or an mRNA vaccine or another COVID-19 vaccine authorized for primary vaccination were offered a single booster dose of Ad26.COV2.S at the 5\*10\^10 vp dose level.
DB Phase (Day 1 up to 6 Months) STARTED	22174	22150	0
DB Phase (Day 1 up to 6 Months) Vaccinated	21898	21890	0
DB Phase (Day 1 up to 6 Months) COMPLETED	21138	20662	0
DB Phase (Day 1 up to 6 Months) NOT COMPLETED	1036	1488	0
DB + OL Phase (2 Years 6.5 Months) STARTED	0	0	43788
DB + OL Phase (2 Years 6.5 Months) COMPLETED	0	0	31593
DB + OL Phase (2 Years 6.5 Months) NOT COMPLETED	0	0	12195

Reasons for withdrawal

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	Combined Double-blind and Open-label Phase: All Participants Participants received a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine or placebo as IM injection on Day 1. At Month 6/unblinding visit, post emergency use authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5\*10\^10 vp. As of implementation of protocol amendment 3, participants were allowed to have an outside COVID-19 vaccine. As of implementation of protocol amendment 6, at Year 1 (open label booster vaccination phase), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) with the Ad26.COV2.S vaccine, and/or an mRNA vaccine or another COVID-19 vaccine authorized for primary vaccination were offered a single booster dose of Ad26.COV2.S at the 5\*10\^10 vp dose level.
DB Phase (Day 1 up to 6 Months) Adverse Event	1	2	0
DB Phase (Day 1 up to 6 Months) Death	34	63	0
DB Phase (Day 1 up to 6 Months) Lost to Follow-up	271	333	0
DB Phase (Day 1 up to 6 Months) Physician Decision	17	17	0
DB Phase (Day 1 up to 6 Months) Protocol Violation	0	1	0
DB Phase (Day 1 up to 6 Months) Withdrawal by Subject	376	714	0
DB Phase (Day 1 up to 6 Months) Other	61	98	0
DB Phase (Day 1 up to 6 Months) Randomized not vaccinated	276	260	0
DB + OL Phase (2 Years 6.5 Months) Adverse Event	0	0	6
DB + OL Phase (2 Years 6.5 Months) Death	0	0	324
DB + OL Phase (2 Years 6.5 Months) Lost to Follow-up	0	0	4978
DB + OL Phase (2 Years 6.5 Months) Physician Decision	0	0	342
DB + OL Phase (2 Years 6.5 Months) Protocol Violation	0	0	2
DB + OL Phase (2 Years 6.5 Months) Withdrawal by Subject	0	0	4332
DB + OL Phase (2 Years 6.5 Months) Other	0	0	2211

Baseline Characteristics

A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants

Baseline characteristics by cohort

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=21898 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=21890 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	Total n=43788 Participants Total of all reporting groups
Age, Continuous	50.7 years STANDARD_DEVIATION 15.08 • n=5 Participants	50.7 years STANDARD_DEVIATION 15.04 • n=7 Participants	50.7 years STANDARD_DEVIATION 15.06 • n=5 Participants
Sex/Gender, Customized Female	9828 Participants n=5 Participants	9907 Participants n=7 Participants	19735 Participants n=5 Participants
Sex/Gender, Customized Male	12067 Participants n=5 Participants	11979 Participants n=7 Participants	24046 Participants n=5 Participants
Sex/Gender, Customized Undifferentiated	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex/Gender, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9875 Participants n=5 Participants	9964 Participants n=7 Participants	19839 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11476 Participants n=5 Participants	11367 Participants n=7 Participants	22843 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	547 Participants n=5 Participants	559 Participants n=7 Participants	1106 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2083 Participants n=5 Participants	2060 Participants n=7 Participants	4143 Participants n=5 Participants
Race (NIH/OMB) Asian	743 Participants n=5 Participants	686 Participants n=7 Participants	1429 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	56 Participants n=5 Participants	47 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4253 Participants n=5 Participants	4262 Participants n=7 Participants	8515 Participants n=5 Participants
Race (NIH/OMB) White	12858 Participants n=5 Participants	12843 Participants n=7 Participants	25701 Participants n=5 Participants
Race (NIH/OMB) More than one race	1207 Participants n=5 Participants	1248 Participants n=7 Participants	2455 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	698 Participants n=5 Participants	744 Participants n=7 Participants	1442 Participants n=5 Participants
Region of Enrollment ARGENTINA	1498 participants n=5 Participants	1498 participants n=7 Participants	2996 participants n=5 Participants
Region of Enrollment BRAZIL	3644 participants n=5 Participants	3635 participants n=7 Participants	7279 participants n=5 Participants
Region of Enrollment CHILE	563 participants n=5 Participants	570 participants n=7 Participants	1133 participants n=5 Participants
Region of Enrollment COLOMBIA	2125 participants n=5 Participants	2123 participants n=7 Participants	4248 participants n=5 Participants
Region of Enrollment MEXICO	238 participants n=5 Participants	241 participants n=7 Participants	479 participants n=5 Participants
Region of Enrollment PERU	886 participants n=5 Participants	885 participants n=7 Participants	1771 participants n=5 Participants
Region of Enrollment SOUTH AFRICA	3287 participants n=5 Participants	3289 participants n=7 Participants	6576 participants n=5 Participants
Region of Enrollment UNITED STATES	9657 participants n=5 Participants	9649 participants n=7 Participants	19306 participants n=5 Participants

PRIMARY outcome

Timeframe: From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6

Population: Per-protocol Efficacy (PP) set: participants of the FAS (all randomized participants with double-blind study vaccine administration, regardless of protocol deviations and serostatus at enrollment) who received double-blind study vaccine and who were seronegative at the time of vaccination and who had no other major protocol deviations to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.

Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription/polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute, oxygen saturation (SpO2) <= 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19400 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=19398 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase Age: Greater than or equal to (>=) 60 years	103 Participants	220 Participants	—	—
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase Age: 18-59 years	381 Participants	847 Participants	—	—

PRIMARY outcome

Timeframe: From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6

Population: PP set included participants of the Full Analysis Set (FAS) who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.

Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >=20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats/minute and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute, SpO2 less than or equal to (<=) 93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the Intensive Care Unit (ICU), death defined as per Food and Drug Administration (FDA) guidance.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19113 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=18924 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase Age: 18-59 years	340 Participants	716 Participants	—	—
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase Age: >=60 years	93 Participants	167 Participants	—	—
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase All participants	433 Participants	883 Participants	—	—

PRIMARY outcome

Timeframe: Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])

Population: Full analysis booster set included all randomized participants with a documented study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment, who received the Ad26.COV2.S booster vaccination at the booster visit.

Participants who received the booster dose were asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=22213 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=613 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster n=943 Participants Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)	3758 Participants	135 Participants	204 Participants	—

PRIMARY outcome

Timeframe: Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])

Population: Full analysis booster set included all randomized participants with a documented study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment, who received the Ad26.COV2.S booster vaccination at the booster visit.

Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=22213 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=613 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster n=943 Participants Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)	3559 Participants	145 Participants	198 Participants	—

PRIMARY outcome

Timeframe: Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1])

Population: Full analysis booster set included all randomized participants with a documented study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment, who received the Ad26.COV2.S booster vaccination at the booster visit.

Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=22213 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=613 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster n=943 Participants Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase)	2133 Participants	58 Participants	95 Participants	—

SECONDARY outcome

Timeframe: From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.

Molecularly confirmed severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance. Seronegative is defined as N-serology seronegative at the time of boosting or at the Year 1 visit if not boosted.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19400 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=19398 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase	56 Participants	205 Participants	—	—

SECONDARY outcome

Timeframe: From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.

Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19113 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=18924 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase	46 Participants	176 Participants	—	—

SECONDARY outcome

Timeframe: 1 day after double-blind vaccination on Day 1 (Day 2)

Population: FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment.

Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=21898 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=21890 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)	575 Participants	1189 Participants	—	—

SECONDARY outcome

Timeframe: 14 days after double-blind vaccination on Day 1 (Day 15)

Population: PP set included participants of the FAS who received double-blind study vaccine, regardless of their serostatus at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. This excludes participants who had a COVID-19 case with an onset before Day 15.

Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=21537 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=21467 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)	487 Participants	1079 Participants	—	—

SECONDARY outcome

Timeframe: 28 days after double-blind vaccination on Day 1 (Day 29)

Population: PP set included participants of the FAS who received double-blind study vaccine, regardless of their serostatus at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. This excludes participants who had a COVID-19 case with an onset before Day 29.

Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=21244 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=20978 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)	436 Participants	895 Participants	—	—

SECONDARY outcome

Timeframe: 14 days after double-blind vaccination on Day 1 (Day 15)

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.

Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation [ECMO], linked to objective measures such as decreased oxygenation, X-ray or computed tomography [CT] findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination were reported.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19400 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=19398 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase)	18 Participants	74 Participants	—	—

SECONDARY outcome

Timeframe: 28 Days after double-blind vaccination on Day 1 (Day 29)

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.

Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and ECMO, linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination were reported.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19113 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=18924 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase)	16 Participants	64 Participants	—	—

SECONDARY outcome

Timeframe: From Day 15 to end of the COVID-19 episode (Day 189)

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded. Here N (Overall number of participants analyzed) signifies participants evaluable for this OM.

AUC of SARS-CoV-2 Viral Load was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=483 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=1041 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Area Under the Curve (AUC) of SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants With Molecularly Confirmed, Moderate to Severe/Critical COVID-19 (Double Blind Phase)	823.7 Log10 copies*day per milliliter Standard Error 33.668	921.47 Log10 copies*day per milliliter Standard Error 25.706	—	—

SECONDARY outcome

Timeframe: 14 Days after double-blind vaccination on Day1 (Day 15)

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.

Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19400 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=19398 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase	11 Participants	15 Participants	—	—

SECONDARY outcome

Timeframe: 28 Days after double-blind vaccination on Day 1 (Day 29)

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.

Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19113 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=18924 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase)	10 Participants	12 Participants	—	—

SECONDARY outcome

Timeframe: 14 Days after double-blind vaccination on Day 1 (Day 15)

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.

Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19400 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=19398 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Double Blind Phase)	492 Participants	1067 Participants	—	—

SECONDARY outcome

Timeframe: 28 Days after double-blind vaccination on Day 1 (Day 29)

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.

Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19113 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=18924 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Double Blind Phase)	441 Participants	884 Participants	—	—

SECONDARY outcome

Timeframe: 14 Days after double-blind vaccination on Day 1 (Day 15)

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 14 in PP set were excluded.

BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19400 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=19398 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase)	495 Participants	1082 Participants	—	—

SECONDARY outcome

Timeframe: 28 Days after double-blind vaccination on Day 1 (Day 29)

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded.

BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19113 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=18924 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase)	443 Participants	895 Participants	—	—

SECONDARY outcome

Timeframe: From Day 29 until end of double-blind phase at Month 6

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a COVID-19 case with an onset or discontinued before day 29 in PP set were excluded.

Number of participants with SARS-CoV-2 seroconversion based on antibodies to nucleocapsid (N) protein using enzyme-linked immunosorbent assay (ELISA) and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 N protein was reported.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19113 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=18924 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Double Blind Phase)	550 Participants	724 Participants	—	—

SECONDARY outcome

Timeframe: Month 6

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine.

Number of participants with asymptomatic infection detected by RT-PCR at the time of the Month 6/unblinding visit were reported.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19113 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=18924 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Double Blind Phase)	10 Participants	12 Participants	—	—

SECONDARY outcome

Timeframe: 28 days after double-blind vaccination on Day 1 (Day 29)

Population: PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Here "N" signifies the excluded participants who had a COVID-19 case with an onset or discontinued before Day 29.

Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) were reported.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=19113 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=18924 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Double Blind Phase)	1038 Participants	1699 Participants	—	—

SECONDARY outcome

Timeframe: 1 day after double-blind vaccination on Day 1 (Day 2)

Population: FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment.

Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance. Seronegative is defined as N-serology seronegative at the time of boosting or at the Year 1 visit if not boosted.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=21898 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=21890 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With First Occurrence of Molecularly Confirmed, Moderate to Severe/Critical COVID-19 for Seronegative Participants (Double Blind Phase)	575 Participants	1189 Participants	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 35 weeks

Population: FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (Overall number of participants analyzed) signifies participants evaluated for this outcome measure.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=21894 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=21882 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Serious Adverse Events (SAEs) (Double Blind Phase)	235 Participants	358 Participants	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to 35 weeks

Population: FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (Overall number of participants analyzed) signifies participants evaluated for this outcome measure (OM).

Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=21894 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=21882 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Adverse Events of Special Interest (AESI) (Double Blind Phase)	6 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: Up to 6 months after double-blind vaccination on Day 1 (up to 6 months)

Population: FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (Overall number of participants analyzed) signifies participants evaluated for this outcome measure.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=21894 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=21882 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Medically-Attended Adverse Events (MAAEs) (Double Blind Phase)	1672 Participants	1885 Participants	—	—

SECONDARY outcome

Timeframe: Up to 35 weeks

Population: FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. Here N (Overall number of participants analyzed) signifies participants evaluated for this outcome measure.

MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases was collected as part of the MAAEs.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=21894 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=21882 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With MAAEs Leading to Study Discontinuation (Double Blind Phase)	1 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: Up to Day 8 (7 Days after double-blind vaccination on Day 1)

Population: Safety population is a subset of FAS for the analysis of solicited local adverse event. Here N (Overall number of participants analyzed) signifies participants evaluated for this outcome measure.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants who were enrolled in safety subset were asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=3356 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=3379 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Double Blind Phase)	1839 Participants	684 Participants	—	—

SECONDARY outcome

Timeframe: Up to Day 8 (7 Days after double-blind vaccination on Day 1)

Population: Safety population is a subset of FAS for the analysis of solicited systemic adverse event. Here N (Overall number of participants analyzed) signifies participants evaluated for this outcome measure.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with pharmaceutical/biological agent under study. Participants who were enrolled in safety subset were instructed on how to record daily temperature using a thermometer provided for home use. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=3356 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=3379 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Double Blind Phase)	2021 Participants	1307 Participants	—	—

SECONDARY outcome

Timeframe: Up to Day 29 (28 Days after double-blind vaccination on Day 1)

Population: Safety population is a subset of FAS for the analysis of unsolicited adverse event. Here N (Overall number of participants analyzed) signifies participants evaluated for this outcome measure.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=3356 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=3379 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Double Blind Phase)	456 Participants	422 Participants	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 29, and Day 71

Population: PPI set included all randomized and vaccinated participants, including those who were part of the immunogenicity subset and for whom immunogenicity data were available, excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here N (Overall number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at specified time points.

Binding antibodies to SARS-CoV-2 S protein as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response was reported. The lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 50.3 EU/mL and 58,158.10 EU/mL, respectively. A sample was considered positive if the value was strictly greater than the LLOQ (>LLOQ).

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=193 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=167 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Double Blind Phase) Day 29	336 ELISA units per milliliter (EU/mL) Interval 284.0 to 398.0	NA ELISA units per milliliter (EU/mL) Here NA signifies that the sample was not positive as Geometric mean, and 95% confidence interval value were less than LLOQ i.e., 50.3 EU/mL.	—	—
Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Double Blind Phase) Day 71	526 ELISA units per milliliter (EU/mL) Interval 437.0 to 633.0	NA ELISA units per milliliter (EU/mL) Here NA signifies that the sample was not positive as Geometric mean, and 95% confidence interval value were less than LLOQ i.e., 50.3 EU/mL.	—	—
Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Double Blind Phase) Baseline (Day 1)	NA ELISA units per milliliter (EU/mL) Here NA signifies that the sample was not positive as Geometric mean, and 95% confidence interval value were less than LLOQ i.e., 50.3 EU/mL.	NA ELISA units per milliliter (EU/mL) Here NA signifies that the sample was not positive as Geometric mean, and 95% confidence interval value were less than LLOQ i.e., 50.3 EU/mL.	—	—

SECONDARY outcome

Timeframe: 28 days after booster vaccination on Day 365 (up to Day 393)

Population: PPI booster analysis set included all participants who received an Ad26.COV2.S booster dose (Year 1(Week 52)/Booster Visit) and who had been selected for inclusion in homologous or heterologous booster subset as of protocol amendment 6. This OM was planned to be analyzed based on homologous and heterologous booster groups. Here, "0" participants in "overall number of participants analyzed" field indicated that data for this OM was not collected and analyzed due to change in planned analysis.

Number of participants with antibody titers to Ad26.COV2.S to measure immune response were reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 29 days after booster vaccination on Day 365 (Day 394)

Population: Per protocol booster immunogenicity analysis set included all participants who received an Ad26.COV2.S booster dose (Year 1 \[Week 52\]/Booster Visit) and who had been selected for inclusion in the homologous or heterologous booster subset as of protocol amendment 6. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. As planned, this outcome measure was analyzed based on homologous and heterologous booster groups.

Number of participants with binding antibodies to SARS- CoV-2S protein as measured by ELISA was reported.

Outcome measures

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=88 Participants Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=29 Participants Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster n=25 Participants Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	Heterologous Booster Group: Inactivated Vaccine + Ad26.COV2.S 5*10^10 vp n=11 Participants As per protocol amendment 6, participants who received placebo in the double-blind phase and had received primary vaccination with inactivated vaccine further received an Ad26.COV2.S 5\*10\^10 vp booster vaccination at Year 1 booster vaccination visit.
Number of Participants With Binding Antibodies to SARS- CoV-2S Protein as Measured by ELISA (Booster Phase)	64 Participants	26 Participants	9 Participants	3 Participants

Adverse Events

Double-blind Phase: Ad26.COV2.S 5*10^10 vp

Serious events: 235 serious events

Other events: 2451 other events

Deaths: 36 deaths

Double-blind Phase: Placebo

Serious events: 358 serious events

Other events: 1653 other events

Deaths: 64 deaths

Combined Double-blind and Open-label Phase: All Participants

Serious events: 2758 serious events

Other events: 0 other events

Deaths: 324 deaths

OL Phase: Ad26.COV2.S 5*10^10 vp + Ad26.COV2.S 5*10^10 vp Booster

Serious events: 0 serious events

Other events: 6048 other events

Deaths: 0 deaths

Open Label Phase: mRNA 2 Dose Schedule + Ad26.COV2.S 5*10^10 vp Booster

Serious events: 0 serious events

Other events: 190 other events

Deaths: 0 deaths

OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster

Serious events: 0 serious events

Other events: 315 other events

Deaths: 0 deaths

Serious adverse events

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=3356 participants at risk；n=21898 participants at risk Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=3380 participants at risk；n=21890 participants at risk Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	Combined Double-blind and Open-label Phase: All Participants n=43788 participants at risk Participants received a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine or placebo as IM injection on Day 1. At Month 6/unblinding visit, post emergency use authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5\*10\^10 vp. As of implementation of protocol amendment 3, participants were allowed to have an outside COVID-19 vaccine. As of implementation of protocol amendment 6, at Year 1 (open label booster vaccination phase), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) with the Ad26.COV2.S vaccine, and/or an mRNA vaccine or another COVID-19 vaccine authorized for primary vaccination were offered a single booster dose of Ad26.COV2.S at the 5\*10\^10 vp dose level.	OL Phase: Ad26.COV2.S 5*10^10 vp + Ad26.COV2.S 5*10^10 vp Booster n=22213 participants at risk Participants received a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine or placebo as IM injection on Day 1. At Month 6/unblinding visit, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM injection at a dose level of 5\*10\^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) were offered a single booster dose of Ad26.COV2.S at the 5\*10\^10 vp dose level as booster vaccination.	Open Label Phase: mRNA 2 Dose Schedule + Ad26.COV2.S 5*10^10 vp Booster n=613 participants at risk Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S as IM injection on Day 1 in the double blind phase and received 2 doses of mRNA vaccination outside of the trial further received an Ad26.COV2.S booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster n=943 participants at risk Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.
Blood and lymphatic system disorders Anaemia	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 18/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Anaemia vitamin B12 deficiency	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Elephantiasis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Granulomatous lymphadenitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 13/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Leukopenia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Nephrogenic anaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Neutropenia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Splenic thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Spontaneous haematoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.05% 24/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Acute cardiac event	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Acute coronary syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 14/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Acute myocardial infarction	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 7/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.12% 53/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Angina pectoris	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Angina unstable	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 10/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Aortic valve stenosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Arrhythmia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 9/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Arteriosclerosis coronary artery	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Atrial fibrillation	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.11% 47/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Atrial flutter	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Atrial tachycardia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Atrioventricular block	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Atrioventricular block complete	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Atrioventricular block second degree	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Atrioventricular node dysfunction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Bradycardia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiac amyloidosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiac arrest	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 12/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiac disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiac failure	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 4/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 19/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiac failure acute	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiac failure chronic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiac failure congestive	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 4/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 16/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiac valve disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiogenic shock	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiomyopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cardiopulmonary failure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Chronic left ventricular failure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Cor pulmonale	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Coronary artery disease	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.08% 35/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Coronary artery occlusion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Coronary artery stenosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Coronary artery thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Left ventricular failure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Mitral valve disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Mitral valve incompetence	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Mitral valve prolapse	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Mitral valve stenosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Myocardial infarction	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.05% 23/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Myocardial ischaemia	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Myocarditis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Palpitations	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Pericarditis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Pericarditis constrictive	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Right ventricular failure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Sinus bradycardia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Sinus node dysfunction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Stress cardiomyopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Supraventricular tachycardia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Tachycardia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Tricuspid valve disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Cardiac disorders Ventricular tachycardia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Congenital, familial and genetic disorders Pseudoxanthoma elasticum	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Congenital, familial and genetic disorders Rathke's cleft cyst	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Congenital, familial and genetic disorders Skeletal dysplasia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Ear and labyrinth disorders Vertigo	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Ear and labyrinth disorders Vertigo positional	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Endocrine disorders Adrenal insufficiency	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Endocrine disorders Basedow's disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Endocrine disorders Endocrine disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Endocrine disorders Goitre	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Endocrine disorders Hyperparathyroidism	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Endocrine disorders Hyperparathyroidism secondary	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Endocrine disorders Hyperthyroidism	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Endocrine disorders Thyroid mass	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Eye disorders Blindness	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Eye disorders Cataract	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Eye disorders Diplopia	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Eye disorders Endocrine ophthalmopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Eye disorders Glaucoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Eye disorders Macular degeneration	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Eye disorders Retinal artery embolism	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Eye disorders Retinal detachment	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Eye disorders Retinal vascular thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Eye disorders Retinal vein thrombosis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Eye disorders Ulcerative keratitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Abdominal compartment syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Abdominal distension	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Abdominal hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Abdominal incarcerated hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Abdominal pain	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Abdominal strangulated hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Abdominal wall disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Acute abdomen	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Anal fistula	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Anal stenosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Colitis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Colitis ulcerative	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Constipation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Crohn's disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Diaphragmatic hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Diarrhoea	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Dysphagia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Enteritis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Enterocolitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Epiploic appendagitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Food poisoning	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gallstone ileus	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastric ulcer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastritis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastritis alcoholic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 10/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastrointestinal ulcer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastrointestinal ulcer perforation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Haematemesis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Haematochezia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Haemorrhoids	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Hernial eventration	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Hiatus hernia	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Hiatus hernia, obstructive	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Ileus	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Ileus paralytic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Inguinal hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 14/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Inguinal hernia strangulated	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Internal hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Intestinal fistula	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Intestinal mass	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Intestinal obstruction	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.05% 23/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Intestinal perforation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Intestinal polyp	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Intestinal pseudo-obstruction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Large intestine perforation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Large intestine polyp	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Lumbar hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Melaena	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Mesenteric panniculitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Nausea	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Oesophagitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Pancreatitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 12/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Pancreatitis acute	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Pancreatitis relapsing	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Peptic ulcer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Peptic ulcer perforation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Small intestinal obstruction	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 16/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Umbilical hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 10/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Vomiting	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Accidental death	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Asthenia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Chest pain	0.01% 3/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.05% 23/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Complication associated with device	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Cyst	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Death	0.03% 7/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 4/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.13% 59/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Drowning	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Drug withdrawal syndrome	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Fatigue	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Gait disturbance	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Generalised oedema	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Illness	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Implant site inflammation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Malaise	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Multiple organ dysfunction syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Non-cardiac chest pain	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Oedema peripheral	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Pain	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Pelvic mass	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Procedural failure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Pyrexia	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Stent-graft endoleak	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Sudden cardiac death	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Sudden death	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 10/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Systemic inflammatory response syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Bile duct stone	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Biliary tract disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Cholangitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Cholangitis acute	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Cholecystitis	0.01% 3/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 18/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Cholecystitis acute	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 19/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Cholecystocholangitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Cholelithiasis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.07% 32/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Dilatation intrahepatic duct acquired	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Hepatic failure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Hepatitis alcoholic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Hepatitis cholestatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Liver injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Immune system disorders ABO incompatibility	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Immune system disorders Allergy to chemicals	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Immune system disorders Anaphylactic reaction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Immune system disorders Anaphylactic shock	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Immune system disorders Drug hypersensitivity	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Immune system disorders Hypersensitivity	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Immune system disorders Sarcoidosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Abdominal sepsis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Abdominal wall abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Abscess limb	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Abscess neck	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Abscess soft tissue	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Acute hepatitis B	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Acute sinusitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Anal abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Appendicitis	0.05% 10/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 8/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.12% 54/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Appendicitis perforated	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Arthritis bacterial	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Arthritis gonococcal	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Arthritis infective	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Atypical pneumonia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Bacteraemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Bacterial diarrhoea	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Bacterial food poisoning	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Bacterial infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Bacterial sepsis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Biliary sepsis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Biliary tract infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Brain abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Bronchitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Bullous erysipelas	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Bursitis infective	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations COVID-19	0.02% 5/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.24% 53/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.33% 146/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations COVID-19 pneumonia	0.04% 9/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.21% 45/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.24% 105/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Campylobacter infection	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Cardiac valve abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Cavernous sinus thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Cellulitis	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.05% 23/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Cholecystitis infective	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Chronic sinusitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Clostridium difficile infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Colonic abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Complicated appendicitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Creutzfeldt-Jakob disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Cystitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Cytomegalovirus infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Dengue fever	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Dengue haemorrhagic fever	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Diabetic foot infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Diarrhoea infectious	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Diverticulitis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 15/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Dysentery	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Encephalitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Endocarditis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Endocarditis bacterial	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Enterobacter sepsis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Epiglottitis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Epstein-Barr virus infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Escherichia bacteraemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Escherichia infection	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Escherichia urinary tract infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Eye abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Focal peritonitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Gangrene	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Gastroenteritis	0.01% 3/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 17/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Gastroenteritis viral	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Gastrointestinal bacterial infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Genital abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations HIV infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Hepatitis B	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Herpes zoster meningitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Implant site infection	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Infected bite	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Influenza	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Labyrinthitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Large intestine infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Laryngitis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Liver abscess	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Lower respiratory tract infection	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 11/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Lung abscess	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Mastoiditis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Medical device site infection	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Meningitis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Meningitis bacterial	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Meningitis cryptococcal	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Meningitis tuberculous	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Meningitis viral	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Monkeypox	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Mononucleosis syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Neurosyphilis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Oesophageal candidiasis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Orchitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Osteomyelitis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 16/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pelvic abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pelvic inflammatory disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Perichondritis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Perineal abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Periorbital cellulitis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Perirectal abscess	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Peritoneal abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Peritonitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Peritonsillar abscess	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pertussis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pharyngitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pharyngitis streptococcal	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pilonidal disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Plasmodium vivax infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pneumonia	0.04% 8/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.06% 13/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.13% 56/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pneumonia aspiration	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pneumonia bacterial	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 18/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pneumonia legionella	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pneumonia pneumococcal	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pneumonia staphylococcal	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pneumonia streptococcal	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pneumonia viral	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Post procedural infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Post procedural sepsis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Postoperative wound infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pseudomembranous colitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pseudomonas infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Psoas abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pulmonary sepsis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pulmonary tuberculosis	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pyelonephritis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pyelonephritis acute	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pyelonephritis chronic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Rectal abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Renal abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Respiratory tract infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Rhinovirus infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Scrotal abscess	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Sepsis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.05% 22/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Septic shock	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 10/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Severe acute respiratory syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Soft tissue infection	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Staphylococcal osteomyelitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Subcutaneous abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Subdiaphragmatic abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Suspected COVID-19	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Thyroglossal cyst infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Tonsillitis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Tooth abscess	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Tuberculosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Typhoid fever	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Upper respiratory tract infection	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Upper respiratory tract infection bacterial	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Urinary tract candidiasis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Urinary tract infection	0.02% 4/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.07% 32/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Urinary tract infection bacterial	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Urosepsis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 10/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Viral infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Wound infection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Accidental exposure to product	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Anastomotic complication	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Anastomotic ulcer haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Animal bite	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 14/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Aortic injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Brachial plexus injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Chemical poisoning	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Chest injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Concussion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Craniocerebral injury	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 12/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Exposure during pregnancy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Face injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Fall	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Femur fracture	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.05% 20/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Gastrointestinal anastomotic complication	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Hand fracture	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Head injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Hip fracture	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 11/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Incarcerated incisional hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Incision site impaired healing	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Joint injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Ligament injury	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Limb injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Lower limb fracture	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Multiple fractures	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Multiple injuries	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Muscle rupture	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Nasal injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Overdose	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Post procedural contusion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Post procedural hypotension	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Post vaccination syndrome	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Prescribed overdose	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Procedural intestinal perforation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Pulmonary contusion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 9/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Road traffic accident	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Seroma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Shunt occlusion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Soft tissue foreign body	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Soft tissue injury	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Spinal cord injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Splenic injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Stab wound	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Testicular injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Thermal burn	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Tibia fracture	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 14/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Tissue injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Traumatic liver injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Ureteric anastomosis complication	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Vascular graft thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Vulvovaginal injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Wound	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Arthroscopy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Blood pressure increased	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Carcinoembryonic antigen increased	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations HIV test positive	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Haemoglobin decreased	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Liver function test increased	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Micrococcus test positive	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Misleading laboratory test result	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Neutrophil count decreased	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Oxygen saturation decreased	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Platelet count decreased	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Pulse absent	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations SARS-CoV-2 test positive	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Thyroid function test abnormal	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Cachexia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Dehydration	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 9/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Gout	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Histamine intolerance	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Obesity	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 17/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Back pain	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 11/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Fracture delayed union	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Immunoglobulin G4 related disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 17/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Joint ankylosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 10/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Meniscal degeneration	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.02% 4/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.12% 54/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Pain in extremity	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 4/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 11/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Spinal disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Spinal instability	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Spinal synovial cyst	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Loss of consciousness	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal neoplasm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic neuroma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoid cystic carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal neoplasm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 9/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder squamous cell carcinoma stage unspecified	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.01% 3/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 4/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.07% 32/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour pulmonary	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system lymphoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal adenocarcinoma of pancreas	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ewing's sarcoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular lymphoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular lymphoma stage I	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular lymphoma stage IV	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gammopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hairy cell leukaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatobiliary neoplasm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 10/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraosseous meningioma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 10/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 12/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma metastatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoplasmacytoid lymphoma/immunocytoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage II	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm of appendix	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm of orbit	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroectodermal neoplasm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma metastatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Lumbar radiculopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the bladder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurofibrosarcoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal squamous cell carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer stage III	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell teratoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian granulosa cell tumour	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary renal cell carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peritoneal mesothelioma malignant	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma recurrent	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.09% 38/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage III	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of head and neck	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 4/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 13/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine neoplasm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Waldenstrom's macroglobulinaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Apallic syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Ascending flaccid paralysis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Bell's palsy	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Brain stem thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Carotid artery aneurysm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Carotid artery disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Carotid artery dissection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Carotid artery occlusion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Carotid artery stenosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Cerebral haemorrhage	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Cerebral infarction	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Cerebral ischaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 8/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Cerebral vasoconstriction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Cerebral venous sinus thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Cerebrospinal fistula	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Cerebrovascular accident	0.01% 3/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 6/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 19/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Cervical radiculopathy	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Cognitive disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Coma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Complex regional pain syndrome	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Dizziness	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Embolic stroke	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Encephalopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Epilepsy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Facial paralysis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Guillain-Barre syndrome	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Haemorrhage intracranial	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Haemorrhagic stroke	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Haemorrhagic transformation stroke	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Headache	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 9/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Hemiparesis	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Hemiplegia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Hepatic encephalopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Hydrocephalus	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Hyperglycaemic seizure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Hypoaesthesia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Idiopathic intracranial hypertension	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Intracranial aneurysm	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Intracranial mass	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Ischaemic stroke	0.01% 3/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.10% 45/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Lacunar stroke	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Metabolic encephalopathy	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Migraine	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Migraine without aura	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Multiple sclerosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Myelopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Nervous system disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Neuralgia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Neuralgic amyotrophy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Neuroglycopenia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Optic neuritis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Paraparesis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Partial seizures	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Presyncope	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Radiculopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Ruptured cerebral aneurysm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Sciatica	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Seizure	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 15/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Spinal cord compression	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Spinal cord haematoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Spondylitic myelopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Syncope	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.06% 28/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Tension headache	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Transient global amnesia	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Transient ischaemic attack	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.06% 27/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Transverse sinus thrombosis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Trigeminal neuralgia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Uraemic encephalopathy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Vertebrobasilar artery dissection	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Abortion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Abortion of ectopic pregnancy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.05% 21/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Cephalhaematoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Foetal death	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Foetal growth abnormality	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions High risk pregnancy	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Premature labour	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Preterm premature rupture of membranes	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Stillbirth	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Pregnancy, puerperium and perinatal conditions Vanishing twin syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Product Issues Device breakage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Product Issues Device dislocation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Product Issues Device failure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Product Issues Device power source issue	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Product Issues Drug delivery system malfunction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Acute psychosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Anxiety	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Bipolar disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Borderline personality disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Catatonia	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Completed suicide	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Confusional state	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Conversion disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Delirium	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Depression	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Depression suicidal	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Intentional self-injury	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Major depression	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Mania	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Mental status changes	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Mixed anxiety and depressive disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Panic attack	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Psychotic disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Schizoaffective disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Schizophrenia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Somatic symptom disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Substance abuse	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Substance dependence	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Substance use disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Suicidal ideation	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 4/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 9/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Suicide attempt	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 4/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 9/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Acute kidney injury	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 16/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Bladder outlet obstruction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Bladder trabeculation	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Calculus urethral	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Calculus urinary	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Chronic kidney disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders End stage renal disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Haematuria	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Hydronephrosis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Hypertonic bladder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Nephritic syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Nephrolithiasis	0.01% 3/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.07% 31/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Renal colic	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Renal cyst	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Renal failure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Renal haematoma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Renal impairment	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Renal injury	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Renal mass	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Ureterolithiasis	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.03% 14/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Urethral obstruction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Urinary bladder rupture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Urinary incontinence	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Renal and urinary disorders Urinary retention	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Abnormal uterine bleeding	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Acquired hydrocele	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Adenomyosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Adnexa uteri mass	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.05% 21/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Breast disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Breast hyperplasia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Breast mass	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Cystocele	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Endometriosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Feminisation acquired	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Ovarian mass	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Pelvic pain	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Premature menopause	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Prostatic disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Prostatic haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Prostatitis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Testicular torsion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Uterine disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Uterine polyp	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.02% 4/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.04% 18/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 9/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.06% 25/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 9/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pharyngeal mass	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pleural mass	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.04% 9/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.11% 50/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.02% 7/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Respiratory, thoracic and mediastinal disorders Tonsillar ulcer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Skin and subcutaneous tissue disorders Angioedema	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Skin and subcutaneous tissue disorders Blister	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Skin and subcutaneous tissue disorders Lipodystrophy acquired	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Social circumstances Miscarriage of partner	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Social circumstances Organ donor	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Social circumstances Physical assault	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Surgical and medical procedures Hospitalisation	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 4/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Aortic aneurysm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Aortic stenosis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Arteriosclerosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Deep vein thrombosis	0.02% 4/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.09% 38/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Embolism venous	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Haematoma	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Hypertension	0.01% 2/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 2/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 6/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Hypertensive crisis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Hypertensive emergency	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Hypertensive urgency	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Hypotension	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 5/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Hypovolaemic shock	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Leriche syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Lymphoedema	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders May-Thurner syndrome	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Orthostatic hypotension	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Peripheral artery aneurysm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Peripheral artery aneurysm rupture	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Peripheral artery occlusion	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Peripheral artery thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Peripheral ischaemia	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Peripheral vascular disorder	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Peripheral venous disease	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Phlebitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Shock	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Thrombophlebitis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 2/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Varicose vein	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Vasospasm	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Vena cava thrombosis	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Venous thrombosis limb	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.01% 3/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Gastrointestinal disorders Pancreatolithiasis	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Infections and infestations Pilonidal cyst	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Investigations Smear cervix abnormal	0.00% 0/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 1/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Brain stem stroke	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Psychiatric disorders Aggression	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Vascular disorders Thrombophlebitis of the right upper limb cephalic vein	0.00% 1/21898 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/21890 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.00% 0/43788 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.

Other adverse events

Measure	Double-blind Phase: Ad26.COV2.S 5*10^10 vp n=3356 participants at risk；n=21898 participants at risk Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1.	Double-blind Phase: Placebo n=3380 participants at risk；n=21890 participants at risk Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1.	Combined Double-blind and Open-label Phase: All Participants n=43788 participants at risk Participants received a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine or placebo as IM injection on Day 1. At Month 6/unblinding visit, post emergency use authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM at a dose level of 5\*10\^10 vp. As of implementation of protocol amendment 3, participants were allowed to have an outside COVID-19 vaccine. As of implementation of protocol amendment 6, at Year 1 (open label booster vaccination phase), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) with the Ad26.COV2.S vaccine, and/or an mRNA vaccine or another COVID-19 vaccine authorized for primary vaccination were offered a single booster dose of Ad26.COV2.S at the 5\*10\^10 vp dose level.	OL Phase: Ad26.COV2.S 5*10^10 vp + Ad26.COV2.S 5*10^10 vp Booster n=22213 participants at risk Participants received a single dose of Ad26.COV2.S 5\*10\^10 vp vaccine or placebo as IM injection on Day 1. At Month 6/unblinding visit, participants initially receiving placebo were offered a single dose of Ad26.COV2.S vaccine IM injection at a dose level of 5\*10\^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccine (as primary regimen or additional dose) were offered a single booster dose of Ad26.COV2.S at the 5\*10\^10 vp dose level as booster vaccination.	Open Label Phase: mRNA 2 Dose Schedule + Ad26.COV2.S 5*10^10 vp Booster n=613 participants at risk Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S as IM injection on Day 1 in the double blind phase and received 2 doses of mRNA vaccination outside of the trial further received an Ad26.COV2.S booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.	OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster n=943 participants at risk Participants who initially received a single dose of placebo vaccine matching to Ad26.COV2.S IM injection on Day 1 in double blind phase and received non-mRNA vaccination outside of the trial or only 1 dose of mRNA vaccination or more than 2 doses of mRNA vaccination further received an Ad26.COV2 booster dose at a dose level of 5\*10\^10 vp at 1 year after the initial vaccination, with a minimum of 3 months after the last outside vaccination.
Gastrointestinal disorders Nausea(Solicited)	16.4% 550/3356 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	10.7% 363/3380 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	4.4% 968/22213 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	5.7% 35/613 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	7.1% 67/943 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Chills	2.1% 70/3356 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.65% 22/3380 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.09% 20/22213 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.49% 3/613 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.32% 3/943 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Fatigue(Solicited)	42.3% 1420/3356 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	24.5% 829/3380 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	11.7% 2589/22213 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	18.8% 115/613 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	16.4% 155/943 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Pyrexia(Solicited)	7.4% 250/3356 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.36% 12/3380 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.76% 169/22213 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	3.3% 20/613 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	1.7% 16/943 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Vaccination site erythema (Solicited)	7.3% 246/3356 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	4.0% 134/3380 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	1.5% 325/22213 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	2.0% 12/613 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	2.9% 27/943 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Vaccination site pain(Solicited)	53.1% 1781/3356 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	17.6% 595/3380 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	16.7% 3702/22213 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	21.9% 134/613 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	21.3% 201/943 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Vaccination site swelling(Solicited)	5.9% 198/3356 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	1.5% 51/3380 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	1.4% 316/22213 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	1.8% 11/613 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	2.2% 21/943 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Musculoskeletal and connective tissue disorders Myalgia(Solicited)	37.1% 1246/3356 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	14.6% 494/3380 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	9.6% 2140/22213 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	17.1% 105/613 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	13.4% 126/943 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Headache (Solicited)	43.3% 1454/3356 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	26.6% 900/3380 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	10.0% 2220/22213 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	15.8% 97/613 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	13.8% 130/943 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
General disorders Fatigue	1.4% 48/3356 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	2.1% 70/3380 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.69% 153/22213 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.82% 5/613 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	2.2% 21/943 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.
Nervous system disorders Headache	1.9% 63/3356 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	2.1% 70/3380 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	— 0/0 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.82% 182/22213 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	0.65% 4/613 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.	1.8% 17/943 • DB phase: All-cause mortality and SAEs: Baseline (Day 1) up to 35 weeks; Other AEs: Day 1 till 28 days after first vaccination; All participants Arm: all-cause mortality and SAEs: Day 1 up to end of study (up to 2 years 6.5 months); Booster treatment groups: Other AEs: from Day 1 till 28 days after booster vaccination on Day 365 (up to Day 393). Solicited AEs: 7 days after first/booster vaccination Per change in planned analysis: data for DB \& OL phase (booster arms) was collected \& reported in 'All participants' arms for all-cause mortality and SAEs. Thus, at risk=0 for booster arms. Other AEs: per plan, Safety subset (subset of FAS) was used and hence at risk=0 for 'All participants' arm as this arm had all treated participants. AEs in DB arms were coded with MedDRA Version 24.0. Same AEs might differ in names in both phases due to coding with different MedDRA versions.

Additional Information

SENIOR ADVISOR CLINICAL DEVELOPMENT

Janssen R&D US

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
• Publication restrictions are in place

Restriction type: OTHER